EUCTR2016-001317-25-ES进行中（未招募）1 期
A Single-Arm, Phase 2 Study of Ramucirumab in Combination with Weekly Docetaxel in Patients with Stage IV Non-Small Cell Lung Cancer Following Disease Progression after Prior Platinum-based Chemotherapy
illy S.A.0 个研究点目标入组 50 人开始时间: 2016年8月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Patients who have had disease progression from prior platinum-based chemotherapy regimen for locally advanced or metastatic NSCLC.
- •- Prior immunotherapy for NSCLC is allowed.
- •- Age of at least 18 years at the time of signing informed consent.
- •- The patient has an Eastern Cooperative Oncology Group performance status of 0 or 1.
- •- The patient has histologically or cytologically confirmed NSCLC.
- •- The patient has metastatic NSCLC disease (Stage IV) at the time of first dose of study treatment.
- •-Patients have measurable disease at the time of first dose of study treatment documented by computed tomography (CT) scan or magnetic resonance imaging (MRI).
- •- The patient has resolution to Grade =1 by NCI-CTCAE, Version 4.0, of all clinically significant toxic effects of prior locoregional therapy, surgery, or other anticancer therapy.
- •- The patient has adequate organ function
- •- The patient’s urinary protein is <2+ on dipstick or routine urinalysis (UA). If urine dipstick or routine analysis indicates proteinuria =2+, then a 24-hour urine must be collected and must demonstrate <2 g of protein in 24 hours to allow participation in the study.
- •- For male patients, are sterile (including vasectomy confirmed by post vasectomy semen analysis) or agree to use a highly effective method of contraception (2 methods preferred, or per country requirements, whichever is more strict), and to not donate sperm starting with the first dose of study treatment, during the study, and for at least 6 months following the last dose of study treatment or country requirements, whichever is longer.
- •- For female patients, are surgically sterile, postmenopausal, or agree to use a highly effective method of contraception (2 methods preferred, or per country requirements, whichever is more strict) during the study and for 6 months following the last dose of study treatment or country requirements, whichever is longer.
- •- Female patients of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to first dose of study treatment.
- •- The patient has a life expectancy of =3 months.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •- Prior therapy with docetaxel or ramucirumab.
- •- The patient has received more than 1 prior chemotherapy regimen for locally advanced or metastatic NSCLC; however, prior maintenance chemotherapy for locally advanced or metastatic NSCLC is allowed.
- •- The patient's tumour contains small cell lung cancer.
- •- The patient has undergone major surgery within 28 days prior to first dose of study treatment, or subcutaneous venous access device placement within 7 days prior to first dose of study treatment. Furthermore, any patient with postoperative bleeding complications or wound complications from a surgical procedure performed in the last 2 months will be excluded.
- •- The patient has a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection (hemicolectomy or extensive small intestine resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea.
- •- The patient has peripheral neuropathy Grade =2 (NCI-CTCAE v 4.0).
- •- The patient has an elective or a planned major surgery during the course of the trial.
- •- The patient is receiving concurrent treatment with other anticancer therapy, including other chemotherapy, immunotherapy, hormonal therapy, chemoembolization, or targeted therapy.
- •- The patient has symptomatic, active, or untreated central nervous system (CNS) metastases. Brain metastases that are asymptomatic, stable and not requiring steroid use, and previously treated by radiation are allowed (refer to Exclusion Criterion [19]). The patient may have no evidence of Grade =1 CNS hemorrhage based on pretreatment MRI or I.V. contrast CT scan (performed within 21 days before first dose of study treatment).
- •- The patient has radiologically documented evidence of major blood vessel invasion or encasement by cancer.
- •- The patient has radiographic evidence of intratumor cavitation, regardless of tumor histology.
- •- The patient has a history of uncontrolled hereditary or acquired thrombotic disorder.
- •- The patient is receiving chronic therapy with nonsteroidal anti-inflammatory drugs (NSAIDs; for example, indomethacin, ibuprofen, naproxen, or similar agents) or other antiplatelet agents (for example, clopidogrel, ticlopidine, dipyridamole, and anagrelide). Aspirin use at doses up to 325 mg/day is permitted.
- •- Patients with a history of gross hemoptysis (defined as bright red blood or =1/2 teaspoon) within 2 months prior to first dose of study treatment.
- •- The patient has clinically relevant congestive heart failure (New York Heart Association Class II-IV) or symptomatic or poorly controlled cardiac arrhythmia.
- •- The patient has experienced any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to first dose of study treatment.
- •- The patient has uncontrolled arterial hypertension =150 / =90 mm Hg despite standard medical management.
- •- The patient has had a serious or nonhealing wound, ulcer, or bone fracture =28 days prior to first dose of study treatment.
- •- The patient has significant bleeding disorders, vasculitis, or experienced Grade 3-4 gastrointestinal (GI) bleeding within 3 months prior to first dose of study treatment.
- •- History of GI perforation and / or fistulae within 6 months prior to first dose of study treatment.
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